Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Merlin 2 PCS MER3700 programmer Model MER3400 software Recalled by St. Jude Medical, Cardiac Rhythm Management Division Due to Due to a programmer software anomaly under very...

Date: March 10, 2022
Company: St. Jude Medical, Cardiac Rhythm Management Division
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical, Cardiac Rhythm Management Division directly.

Affected Products

Merlin 2 PCS MER3700 programmer Model MER3400 software

Quantity: 401 devices with software

Why Was This Recalled?

Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report